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Teen Mom 2: Improving Black Adolescent Maternal Cardiometabolic Health

Primary Purpose

Physical Activity, Sedentary Behavior, Gestational Weight Gain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Health Coaching
#BabyLetsMove
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity focused on measuring implementation science, pragmatic clinical trial, telemedicine, health disparity, minority and vulnerable populations, behavior and behavior mechanisms, adolescent pregnancy, black maternal health

Eligibility Criteria

15 Years - 25 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Peer Health Coaches Inclusion Criteria: 18- to 15-years Black or African American >6-months postpartum Enrolled in WIC English speaking High school diploma or GED Peer Health Coaches Exclusion Criteria: Illiteracy #BabyLetsMove Inclusion Criteria: 15- to 19-years Black or African American <20 weeks' gestation Enrolled in WIC Residing in 1 of 8 Mississippi Delta Counties English speaking Own or have personal use of a mobile smart phone Singleton pregnancy Plan to carry the fetus to term and keep the infant after birth No history of chronic medical conditions in the past year that could influence weight loss or gain #BabyLetsMove Exclusion Criteria: Restrictions on physical activity or exercise

Sites / Locations

  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peer Health Coaching

#BabyLetsMove

Arm Description

Young adult (18- to 25-years), postpartum, Black women enrolled in WIC will undergo paid training in health coaching.

There are four digital components to the intervention including Fitbit activity tracker, interactive self-monitoring and tailored feedback text messages, tailored skills training text messages and materials, and peer health coaching.

Outcomes

Primary Outcome Measures

Moderate-to-vigorous physical activity (MVPA)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Hesketh et al. (2018) for moderate (1952 - 5724 counts per minute) and vigorous (>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Sedentary behavior (SB)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Moderate-to-vigorous physical activity (MVPA)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Hesketh et al. (2018) for moderate (1952 - 5724 counts per minute) and vigorous (>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Sedentary behavior (SB)
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
April 24, 2023
Sponsor
University of Mississippi Medical Center
Collaborators
Mississippi State Department of Health, Health Resources and Services Administration (HRSA), National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05843903
Brief Title
Teen Mom 2: Improving Black Adolescent Maternal Cardiometabolic Health
Official Title
Teen Mom 2: A Multicomponent Digital Health Intervention to Improve Black Adolescent Maternal Cardiometabolic Health in Mississippi's WIC Community
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
Mississippi State Department of Health, Health Resources and Services Administration (HRSA), National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed multicomponent digital health intervention has the potential to significantly impact the trajectory of maternal health in a rural, pregnant, Black adolescent population with the highest risks for cardiometabolic diseases worldwide. The proposed implementation strategy leverages mobile technologies which are ubiquitous across the socioeconomic gradient and proposes to train young adult WIC moms to deliver peer health coaching in a telehealth setting to address social barriers and support behavior change in pregnant, Black adolescent WIC clients in the Mississippi Delta - a rural region where the population is more than two-thirds percent Black and the teen birth rate is the highest in the United States. This is a scalable and sustainable approach to enhance WIC services and improve WIC's impact on population health and cardiometabolic health disparities in Black women.
Detailed Description
Teen Mom 2 will assess the feasibility, acceptability, and early efficacy of a 20-week multilevel, multicomponent digital health intervention, #BabyLetsMove, delivered through the University of Mississippi Medical Center's Telehealth Center for Excellence in partnership with the Special Supplemental Nutritional Program for Women, Infants, and Children (WIC) to increase physical activity (PA) and reduce sedentary behavior (SB) in pregnant, Black adolescent WIC clients in the Mississippi Delta. The Social Ecological Model and TElehealth in CHronic Disease Model provide an empirical framework for considering multiple determinants of health behavior and evaluating mechanisms of implementation and intervention impacts. At the person level, pregnant, Black adolescent (15- to 19-years) WIC clients (n=70) will be given three empirically supported behavior goals to (1) watch 2 hours or less of television per day, (2) take 10,000 steps or more per day, and (3) engage in 20 minutes or more of organized exercise like prenatal yoga or dance videos per day. The intervention is designed to build social cognition, affect, and skills using four intervention components including a Fitbit activity tracker, interactive self-monitoring text messages with tailored feedback, tailored skills training text messages and materials, and peer health coaching. At the systems-level, racially concordant young adult (20- to 25-years) WIC moms (n=8) will be hired and trained to deliver peer health coaching in a telehealth setting to first, address social needs and second, to provide support for achieving the three behavior goals. The specific aims are to: (1) assess the impact of #BabyLetsMove on objectively measured light-to-moderate PA and SB from baseline (<20-weeks' gestation) to 26- and 36-weeks' gestation in pregnant, Black adolescents; (2) use remote patient monitoring to objectively measure and characterize patterns of weight gain from baseline to 26- and 36-weeks' gestation; and (3) evaluate the feasibility and acceptability of training young adult WIC moms to provide health coaching in a telehealth setting. This study will advance public health and scientific knowledge in preparation for a future cluster randomized clinical trial by: training WIC moms to provide health coaching to pregnant, Black adolescents in a telehealth setting; developing an attention-control arm; assessing changes in adolescents' PA and SB throughout pregnancy in response to a 20-week intervention; characterizing patterns of weight gain throughout pregnancy in Black adolescents; comparing adolescents across counties and WIC providers; and evaluating an implementation partnership between WIC and the Telehealth Center of Excellence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Sedentary Behavior, Gestational Weight Gain, Social Determinants of Health
Keywords
implementation science, pragmatic clinical trial, telemedicine, health disparity, minority and vulnerable populations, behavior and behavior mechanisms, adolescent pregnancy, black maternal health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peer Health Coaching
Arm Type
Experimental
Arm Description
Young adult (18- to 25-years), postpartum, Black women enrolled in WIC will undergo paid training in health coaching.
Arm Title
#BabyLetsMove
Arm Type
Experimental
Arm Description
There are four digital components to the intervention including Fitbit activity tracker, interactive self-monitoring and tailored feedback text messages, tailored skills training text messages and materials, and peer health coaching.
Intervention Type
Behavioral
Intervention Name(s)
Peer Health Coaching
Intervention Description
Young adult, Black WIC moms will be trained as peer health coaches to first, address social needs and second, support health behavior change in pregnant, Black adolescents enrolled in WIC. Health coaching is a client-centered technique that leverages the power of lived experiences and motivational interviewing to strengthen one's drive for behavior change by linking personal goals with values. Training racially concordant health coaches will mitigate internalized and interpersonal racism, leverage moms' connection with WIC, and supplement WIC services by providing a scalable telehealth peer health coaching intervention.
Intervention Type
Behavioral
Intervention Name(s)
#BabyLetsMove
Intervention Description
The #BabyLetsMove digital health intervention uses a multi-level, systems-change approach. At the systems-level, racially concordant young adult WIC moms will be trained as health coaches. At the person level, adolescent WIC clients will be given empirically supported behavior goals, self-monitoring text messages with automated feedback, tailored skills training materials, a FitBit device, and tailored peer coaching support. The #BabyLetsMove intervention design is based on formative Teen Mom Study findings to build social cognition, affect, and skills to modify 3 concrete, achievable, and easily monitored behavioral targets: (1) Limit television viewing time to less than 2 hours per day; (2) Walk at least 10,000 steps per day; and (3) Do 20 minutes or more of exercise per day.
Primary Outcome Measure Information:
Title
Moderate-to-vigorous physical activity (MVPA)
Description
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Hesketh et al. (2018) for moderate (1952 - 5724 counts per minute) and vigorous (>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Time Frame
Change in MVPA from baseline (<20-weeks' gestation) to 26-weeks' gestation.
Title
Sedentary behavior (SB)
Description
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Time Frame
Change in SB from baseline (<20 weeks' gestation) to 26-weeks' gestation.
Title
Moderate-to-vigorous physical activity (MVPA)
Description
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Hesketh et al. (2018) for moderate (1952 - 5724 counts per minute) and vigorous (>5724 counts per minute) PA. Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Time Frame
Change in MVPA from baseline (<20-weeks' gestation) to 36-weeks' gestation.
Title
Sedentary behavior (SB)
Description
GT9X ActiGraph accelerometer. Accelerometers will be worn on participants' non-dominant wrist for 7-days, 24-hours per day to record raw acceleration data using a sampling rate of 100 Hz that will be converted into objective measures. Counts will follow Clark et al. (2021) for SB (<100 counts per minute). Wear-time compliance will include 20 hours per day, > 4 days per week including 1 weekend day.
Time Frame
Change in SB from baseline (<20-weeks' gestation) to 36-weeks' gestation.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Peer Health Coaches Inclusion Criteria: 18- to 15-years Black or African American >6-months postpartum Enrolled in WIC English speaking High school diploma or GED Peer Health Coaches Exclusion Criteria: Illiteracy #BabyLetsMove Inclusion Criteria: 15- to 19-years Black or African American <20 weeks' gestation Enrolled in WIC Residing in 1 of 8 Mississippi Delta Counties English speaking Own or have personal use of a mobile smart phone Singleton pregnancy Plan to carry the fetus to term and keep the infant after birth No history of chronic medical conditions in the past year that could influence weight loss or gain #BabyLetsMove Exclusion Criteria: Restrictions on physical activity or exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Gamble, PhD, MS
Phone
601-815-9065
Email
agamble2@umc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail Gamble, PhD, MS
Organizational Affiliation
University of Mississippi Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abigail Gamble, PhD, MS
Phone
601-815-9065
Email
agamble2@umc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34271198
Citation
Gamble A, Beech BM, Blackshear C, Herring SJ, Welsch MA, Moore JB. Changes in Physical Activity and Television Viewing From Pre-pregnancy Through Postpartum Among a Socioeconomically Disadvantaged Perinatal Adolescent Population. J Pediatr Adolesc Gynecol. 2021 Dec;34(6):832-838. doi: 10.1016/j.jpag.2021.06.009. Epub 2021 Jul 13.
Results Reference
background
PubMed Identifier
33737198
Citation
Gamble A, Beech BM, Blackshear C, Cranston KL, Herring SJ, Moore JB, Welsch MA. Recruitment planning for clinical trials with a vulnerable perinatal adolescent population using the Clinical Trials Transformative Initiative framework and principles of partner and community engagement. Contemp Clin Trials. 2021 May;104:106363. doi: 10.1016/j.cct.2021.106363. Epub 2021 Mar 15.
Results Reference
background
PubMed Identifier
32732725
Citation
Gamble A, Saulters MM, Cranston KL, Jones DW, Herring SJ, Beech BM. Recruitment, Retention, and Engagement Strategies for Exercise Interventions With Rural Antenatal Adolescents: Qualitative Interviews With WIC Providers. J Public Health Manag Pract. 2020 Sep/Oct;26(5):497-502. doi: 10.1097/PHH.0000000000001027.
Results Reference
background

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Teen Mom 2: Improving Black Adolescent Maternal Cardiometabolic Health

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